Lead Submission Coordinator EU CTR

Johnson & Johnson; Warszawa; On-site; PLN 210,000 - 403,000; Full time

Job summary

Johnson & Johnson is seeking a Lead Submission Coordinator EU CTR to join our team in Prague, Czech Republic or Warsaw, Poland. You will coordinate operational and strategic EU CTR submissions for the EU/EEA region, collaborating with global and country teams to ensure timely CTIS documentation throughout the trial lifecycle.

You will lead submission strategy, manage the submission plan, milestones and RFI processes, coordinate with stakeholders, and act as SME for EU CTR submissions while

Qualifications

• Bachelor's degree required; advanced degree preferred.
• Min 7 years in R&D or Regulatory Affairs or related function.
• English fluency and strong communication skills.
• Excellent project management and presentation abilities.
• Deep EU CTR knowledge with experience in submissions.
• Proven results orientation and stakeholder collaboration.
• Ability to lead cross-functional projects and onboarding.

Responsibilities

• Lead the EU CTR submission strategy development, planning and delivery.
• Coordinate meetings with stakeholders and facilitate discussions.
• Create and maintain the operational submission plan and track progress.
• Lead EU CTR application process from planning to approval.
• Coordinate documentation, RFI process and CTIS uploads.
• Serve as SME for EU CTR submissions and drive cross-functional initiatives.

Skills

Project management

English fluency

Communication

AI literacy

Regulatory affairs

Stakeholder management

Education

Bachelor's degree

Advanced degree preferred

Tools

Microsoft Office

CTMS

PM tools

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Prague, Czechia, Warsaw, Masovian, Poland

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

Johnson & Johnson is currently seeking a Lead Submission Coordinator EU CTR to join our team located in Prague, Czech Republic or Warsaw, Poland.

The Lead Submission Coordinator EU CTR is responsible for coordinating the operational and strategic submission aspects of EU clinical trial applications for the EEA region for internally managed trials. The Lead Submission Coordinator EU CTR collaborates with global and country teams to ensure all information and documentation for the submission to EMA’s Clinical Trial Information System (CTIS) are provided in a timely manner basis throughout the lifecycle of a clinical trial.

Principal Responsibilities:

• Lead the operational EU CTR Submission strategy development, planning and delivery.

• Set up and attend relevant trial alignment, kick-off and planning meetings with all relevant stakeholders and facilitate discussions via scenario planning with a view to agree the final EU CTR submission strategy.

• Create and maintain the operational submission plan, in close collaboration with internal stakeholders Lead the EU CTR application process from operational planning to application (initial and modifications) approval.

• Coordinate timely and accurate documentation, communicate submission progress and issue escalation.

• Manage the internal systems to support EU CTR package planning and delivery.

• Ensure required reports are generated and available for real time tracking of trial status.

• Coordinate the RFI process in close collaboration with the internal partners.

• Coordinate upload to CTIS.

• Act as the primary contact person for EU CTR submissions in the Study Team.

• Demonstrate deep knowledge of the EU CTR submissions process and CTIS requirements, provide input to trial teams.

• Lead complex or challenging applications, including senior level reporting.

• Act as SME for designated areas.

• Lead cross functional projects (initiatives) or meetings in relation to operating model enhancements.

Education and Experience Requirements:

• Bachelor’s degree requires, advanced degree preferred.

• Minimum of 7 years’ experience working in Research & Development or Regulatory Affairs, or related function required.

• Demonstrated AI literacy and an AI enabled mindset, including the ability to apply AI tools responsibly in daily work to improve productivity, decision making and quality of outcomes.

• Excellent project management, presentation and communication skills required.

• Deep understanding of EU CTR and proven track record in either EU CTR submissions or multinational clinical trial submissions under the EU Clinical Trial Directive.

• Demonstrated experience being solutions and results oriented required.

• Ability to partner, influence and lead with a customer first mindset required.

• Ability to prioritize requests in alignment with the internal clients and propose effective alternatives when necessary required.

• Ability to onboard new staff as Submission Coordinator EU CTR.

• Demonstrated proficiency with the Microsoft Office Suite, and metric reporting and project management tools preferred.

• Language Requirement: Fluency in English

• Travel Percentage: 10% (Domestic & International)

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)

The anticipated pay range for this position, in the primary posting location, is:

zł210,000.00 - zł402,500.00

The anticipated pay ranges for additional locations are:

Czech Republic - The anticipated base pay range for this position is 1,028,000 CZK - 1,967,650 CZK

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.